Table 1.
Summary of exposure in Japanese patients for the exposure‐response safety analysis
Summary exposure, µg/mL | Geometric mean (CV%) | % Difference | Median (P05, P95) | ||
---|---|---|---|---|---|
240 mg Q2W | 3 mg/kg Q2W | 240 mg Q2W | 3 mg/kg Q2W | ||
Cavgd28 | 44.6 (21.4) | 32.5 (20.6) | 37.2 | 44.8 (31.6, 61.7) | 32.8 (21.9, 45.2) |
Cmind28 | 38.4 (27.7) | 27.9 (25.8) | 37.6 | 38.9 (23.5, 59.5) | 29.3 (16.5, 41.3) |
Cmax1 | 76.1 (21.0) | 55.3 (18.3) | 37.6 | 75.4 (54.6, 108.0) | 55.0 (40.7, 73.4) |
Cavgd28, nivolumab concentration over the first 28 d; Cmax1, peak concentration after the first dose; Cmind28, trough concentration at day 28; CV, coefficient of variation; P05, fifth percentile; P95, 95th percentile; Q2W, every 2 wk.